View all FDA related documents for 10x'20

IDSA comments to FDA on the agency's recent final guidance for industry on hospital-acquired and ventilator-acquired bacterial pneumonia (HABP/VABP) clinical trials. IDSA welcomes the agency's progress making clinical trials more feasible and offers recommendations to improve the guidance.

IDSA comments to FDA on the agency's recent guidance for industry on community-acquired bacterial pneumonia (CABP) clinical trials. IDSA applauds the agency's efforts to make clinical trials more feasible and offers recommendations to improve the guidance.

IDSA submitted comments on U.S. Food and Drug Administration (FDA) draft document "Guidance for Industry: Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious Bacterial Infections." In the letter, IDSA supports the FDA's current efforts to streamline clinical trials and approvals for pathogen-specific antibacterial drugs and stresses the need for legislation that would provide additional critical safeguards to help ensure appropriate, narrow use of these new drugs.

IDSA, with endorsement from the Pediatric Infectious Diseases Society (PIDS), submitted comments to FDA calling for stronger communication between FDA, CDC, the pharmaceutical industry, and health care practitioners to identify actions that can be taken to prevent drug shortages that impact patient care and public health.

IDSA praised FDA for several elements of the guidance, including the acceptability of a single adequate and well controlled study with supportive data as evidence of effectiveness, the use of clinical and microbiological endpoints, the noninferiority margin, and the willingness to accept a greater degree of risk where there is a serious unmet need. IDSA asked FDA to reconsider areas of concern, including allowance of a switch to oral administration of drugs and allowance of 48 hours of prior non-trial antibiotics.

Workshop summary of the Clinical Trials Transformation Initiative (CTTI) on the topic of Anti-Bacterial Drug Development: Issues in the Design of Trials in Patients with Unmet Need and in Patients with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia.

IDSA praised the FDA for its effort to develop the draft guidance and for the inclusion of various elements, including clinical and microbiological endpoints, emphasis on pharmacokinetic data to support phase III trials, and incorporation of rapid diagnostic testing. IDSA raised concerns with precluding prior antimicrobial therapy, the long duration of therapy, the maintenance of IV therapy for the duration of treatment, patient inclusion criteria, and the non-inferiority margin.

IDSA joined over 75 provider and patient advocacy organizations in urging Senate leaders to eliminate over-the-top conflict of interest requirements that apply only to Food and Drug Administration advisory committees. These requirements tie FDA's hands preventing the agency from hearing opinions from the most knowledgeable experts prior to approving new drugs, vaccines, diagnostics, etc.

The Society would like FDA to engage the Institute of Medicine to develop a process for reviewing FDA's current approaches to anti-infective clinical trial designs for both antibacterial and influenza antiviral drugs as the current approach has produced infeasible instructions for industry and continues to stymie new drug development in these critical areas.

This background paper by Brad Spellberg, MD, FIDSA (a member of IDSA's Antimicrobial Availability Task Force) examines the two primary types of clinical trials for new drugs and concludes that non-inferiority trials are the only clear pathway for approval of new antibiotics.

IDSA notes that FDA Appropriations Chairwoman appears to have received some faulty information when she took FDA to task on its plans to update antibacterial breakpoints on drug labeling (e.g., we disagree that the agency is "outsourcing" this essential function to the Clinical Laboratory Standards Institute).

In a letter to FDA Commissioner Peggy Hamburg, IDSA requests a meeting with top agency officials to discuss issues and strategies related to novel H1N1 influenza, impediments to antibacterial drug development, strategies to better address antimicrobial resistance and the use of antimicrobials in animals.

In its comments, IDSA raised concerns about FDA's proposal to approve new antivirals for influenza based on superiority or dose-ranging trials vs. non-inferiority trials. IDSA also is concerned about FDA's adherence to Pediatric Research Equity Act requirements, which may act as an impediment to drug development in this critical area.

IDSA, American Thoracic Society, American College of Chest Physicians, Society for Critical Care MEdicine, and the U.S. Food and Drug Administration co-sponsor a March 31-April 1, 2009 public workshop on clinical trial design for hospital-acquired pneumonia and ventilator-associated pneumonia.

A workshop that brought together the collective expertise of industry, academia, and the regulatory agency to address practical issues in conducting clinical trials of antibacterial agents for the treatment of patients with hospital-acquired pneumonia.

IDSA met with FDA officials on August 25th to continue its dialogue with FDA on the relevance of the Orphan Drug Act to serious infections caused by resistance organisms. This letter summarizes key points raised during that meeting and seeks FDA's confirmation of these points.

IDSA seeks clarification on inconsistent statements made by agency officials about the relevance of the Orphan Drug Act to resistant infections and asks whether a parallel regulatory framework with incentives similar to, but not the same as, the Orphan Drug program could stimulate antibacterial drug, and related diagnostic vaccine, research and development.